Kornimate/medical-research-clean huggingface dataset:
nutritional status in children with all in guatemala

Conditions: Acute Lymphoblastic Leukemia

Summary: this study proposes to investigate the association of nutritional status of a children assessed by body mass index (bmi), triceps skinfold thickness (tsft), and mid upper arm circumference (muac), with body composition, measured by dual-energy x-ray absorptiometry (dexa), in 60 children undergoing treatment of all at unidad nacional de oncologia pediatrica (unop), in guatemala city, guatemala. the study also aims to establish normative values of body composition in children residing in an lmic by examining 160 healthy siblings of children under treatment, and to measure habitual physical activity in children with acute lymphoblastic leukemia (all) at diagnosis and during therapy.

the majority of children with cancer live in low and middle income countries (lmics) where malnutrition, both under and over nutrition, is highly prevalent. children who are malnourished while undergoing treatment for acute lymphoblastic leukemia (all) are shown to have chances of reduced survival. children, who are malnourished at diagnosis, if the nutritional status is improved over the course of 6 months during the all treatment, have chances of similar survival as the ones who were nourished throughout. therefore, it is important to study nutritional status in children with all, to understand and implement better treatment outcomes. height and weight alone are considered incomprehensive in classifying nutritional status, especially in poorly nourished children. a more advanced nutritional assessment that distinguishes between fat and muscle mass is required. treatment for all results in an increase in weight over the course of therapy with preferential gain in fat mass (fm) compared to fat free mass (ffm). hence, there is a pressing need to advance nutritional assessment and implementation in pediatric oncology that includes monitoring of fm and ffm.

Eligibility criteria:
inclusion criteria: * children under treatment for acute lymphoblastic leukemia (all) * age under 18 years * getting treatment at unop exclusion criteria: * if they can't participate in the study due to illness or long distance to travel to unop

Keywords: guatemala guatemala city malnutrition leukemia childhood cancer
examining how a facilitated self-sampling intervention and testing navigation intervention influences covid-19 testing

Conditions: COVID-19

Summary: antigen self-testing kits are more available at this stage in the pandemic, but among vulnerable populations, use is still low and instructions for antigen testing are not typically designed for low health literacy populations. studies are needed to explore access and use of antigen tests among vulnerable populations and examine if low-health-literacy-designed interventions improve covid-19 testing decisions and behaviors. this study will focus on understanding factors associated with rapid covid-19 testing, specifically. the primary objectives of the embedded study are to 1) determine the effectiveness of community-level intervention using door-to-door recruitment and education in increasing covid-19 testing and 2) compare the effectiveness of the chw- facilitated self-sampling intervention (fssi) vs. chw testing navigation intervention (tni).

the pandemic landscape and people's experiences with testing, infection, and vaccination have changed dramatically over the past two years. vaccines have become available, testing access in local communities has waxed and waned, and attitudes toward covid-19 severity and susceptibility have shifted. navigating the testing-decision landscape is confusing to the public (test availability for free versus charged or requiring insurance; testing and vaccination locations change; pcr versus antigen testing; home tests versus clinically delivered; symptom-based testing, exposure-driven testing, serial testing, resources to trust or not trust, etc.). this study, referred to as the embedded study, builds off a broader population-based group randomized controlled trial (rct) to evaluate the effects of a facilitated self-sampling intervention and testing navigation intervention on testing behaviors. the embedded study will randomly select and assign priority block groups from the rct to one of three arms - fssi (n=16), tni (n=16), or control (n= 32). the allocation will be at a 2:1:1 rate across the three regions houston/harris county, south texas, and northeast texas respectively. community health workers will systematically sample and recruit 20 individuals from each pbg using a random start procedure. study participants in the intervention arms will be enrolled, complete a baseline survey, receive a brief educational intervention, and complete a follow-up survey. participants in the control arm will complete a baseline and follow-up survey.

Eligibility criteria:
inclusion criteria: * aged 18 years or older exclusion criteria: * having been diagnosed with covid-19 in the past 30 days based on a positive test (antigen or pcr) or a clinical diagnosis * having tested for covid-19 with pcr or antigen test within the past 30 days

Keywords: covid-19 antigen testing decision making testing behaviors vulnerable populations social networks
development & validation of utilities for health states relevant to cervical cancer patients

Conditions: Cervical Cancer

Summary: purposes of this study: 1) to define comprehensive set of descriptive health states related to treatment of cervical cancer (e.g. radical hysterectomy, whole pelvic radiation, brachytherapy, chemoradiation) 2) to define set of descriptive health states related to adverse events associated w treatment of cervical cancer (i.e. bladder dysfunction, pain, enteritis, fistula formation) \& 3) to derive, using a validated method, a set of qol related utility scores corresponding to these health states.

subjects will valuate cervical cancer-related health states using the visual analog score (vas) and tto (tto) methods. the subject will be asked to read a pertinent health state description and listen while it is read aloud. she will first be asked to place the state on a continuum (vas) from zero to 100, with 100 presenting perfect health and zero presenting death. the tto interview will then be administered. the subject will be asked to assume a remaining life expectancy of 30 years, and to choose between 30 years in the health state described or 29 years in a state of perfect health. the utility of the health state, a number between zero and one, is calculated as the minimum number of years the patient would accept divided by 30. each subject will be asked to review and valuate 20 health states over the course of 60-90 minutes.

Eligibility criteria:
inclusion criteria: * any member of public over age of 18 and without the diagnosis of cervical cancer can participate in this study. * patients over the age of 18 with the diagnosis of cervical cancer are eligible to participate in this study. exclusion criteria: * any member of public under the age of 18 or with a prior diagnosis of cervical cancer is excluded from this study. * any cervical cancer patient younger than 18 is excluded from this study.

Keywords: radical hysterectomy whole pelvic radiation brachytherapy chemoradiation complications quality of life
an intervention to promote healthy behaviors in homeless youth

Conditions: Substance Use Disorders

Summary: investigators will use a solomon 4-group design to test the effectiveness of a brief intervention to promote health behaviors for homeless youth who are 18-23 years of age. we will recruit 300 youths from austin, tx and 300 from columbus, oh. we will gather quantitative data on health behaviors and life satisfaction 3 and 6 months following the intervention, which will be delivered on an individual basis. data will be analyzed using structural equation modeling and ancova statistics.

the specific aims of this proposal are to: 1. determine the effectiveness of a self-reflective preventive intervention to promote responsible substance use and safe sex behaviors (prevent hiv/aids) in homeless youths, ages18-23 years; 2. determine whether psychological capital factors mediate the relationship between background risk factors (sexual orientation, duration of homelessness, sex abuse history, history of substance use, past sexual risk behaviors, and service utilization) and improved proximal outcomes (self-efficacy and intentions) and distal outcomes (responsible substance use, safer sex, life satisfaction); 3. determine the effect of pre-testing on intervention proximal outcomes (immediately following intervention) and distal outcomes (at an interval of 3 and 6 months following intervention); and an exploratory aim 4. to explore general and specific differences in proximal and distal outcomes of the intervention between participants in two geographically different sites (austin, tx and columbus, oh). we will recruit a total of 600 homeless youths from 2 drop-in centers in 2 geographic areas of the central us: austin, tx and columbus, oh. using a solomon four-group design with repeated measures, we will conduct a randomized controlled trial of a brief possible selves intervention (psi) consisting of 6 brief individualized sessions that focus on generating images of one's possible self as feared or as best. intervention participants will also receive weekly electronic messages to encourage them to move toward a goal of becoming their best possible self. quantitative data will be collected before, immediately after the intervention, and at intervals of 3 and 6 months following intervention to test hypotheses about the effectiveness of the intervention on health behaviors and life satisfaction as well as the effects of pre-testing on these outcomes using structural equation modeling and ancova statistics. the findings are expected to have a public health impact on further development of individualized services to promote healthy behaviors, healthy lifestyles and life satisfaction for vulnerable youths.

Eligibility criteria:
inclusion criteria: * does not have current secure place of residence, * receives services from a homeless street outreach center, and * is able to read and write english exclusion criteria: * currently enrolled in alcoholics anonymous or other substance treatment program
high intensity resistance training and possible sarcopenia

Conditions: Sarcopenia

Summary: studies conducted so far added the dietary supplements along with resistance training as an intervention, we could not determine whether the observed effects of the intervention were due to the training program and/or dietary supplements.

this study will investigate the effects of high intensity resistance training solely in the possible sarcopenia cases which has not done before, to author's knowledge. furthermore this study will help clinicians to individualize and optimize the therapy for specific patient subgroups, improve the potential of this therapy to improve human function and well being, facilitate timely interventions in community healthcare and prevention settings, which will contribute to higher awareness of sarcopenia prevention and interventions in diverse health care settings.

Eligibility criteria:
inclusion criteria: * both male and female * age more than 60 years * possible sarcopenia cases as defined by asian working group for sarcopenia (handgrip strength: male less than 26kg and female less than 18kg, 5 time chair stand test more than/equals to 12 seconds) exclusion criteria: * orthopedic surgery in last one year * neurological disorders like stroke etc * history of recent fractures * metabolic disorders like dm etc * actively involved in exercise programs * cognitive impairment that could confound the assessment * wheelchair or bed bound individuals
study of single doses of sbt777101 in subjects with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this study will test the safety and effects of sbt777101 when given as a single dose to subjects with rheumatoid arthritis. it is the first study of this treatment being done in humans. increasing dose levels will be given after the safety at lower dose levels is shown.

the study evaluates the safety and effects of a novel regulatory cartreg cell-based autoimmune and inflammatory disease therapy for the treatment of rheumatoid arthritis. the therapy is an autologous (using the patient's own cells) treg cell therapy that targets proteins in the inflamed, disease-associated tissue, with the aim to dampen inflammation and restore balance to the immune system.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) \<35 kg/m\^2, inclusive * adult-onset, moderate-to-severe rheumatoid arthritis (ra) * moderate-to-severe active disease * clinical and/or ultrasound evidence of synovitis * prior inadequate response to or unable to tolerate available ra therapies * stable doses of ra medications for at least 30 days * use of highly effective methods of contraception exclusion criteria: * major surgery within 12 weeks prior to screening or planned within 12 months after dosing * uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease * recurrent infections or active infection * active or untreated latent tuberculosis * primary or secondary immunodeficiency * history of or current inflammatory joint disease other than ra

Keywords: rheumatoid arthritis safety regulatory t cells cart treg inflammatory disease autoimmune disease autologous cell therapy
long-term efficacy and safety of subjects approximately 3 years after priming with 2 doses of gsk bio's hrv vaccine.

Conditions: Infections, Rotavirus

Summary: to assess the long-term efficacy and safety of the subjects during the third year after priming with 2 doses of gsk biologicals' oral live attenuated hrv vaccine (rotarix) in the primary vaccination study (102247). the rotarix vaccine was administered in the primary vaccination study. there was no vaccine/intervention in this long-term efficacy study.


Eligibility criteria:
inclusion criteria: * a male or female who has completed the second year efficacy follow-up of the primary vaccination study in finland. * written informed consent obtained from the parent or guardian of the subject.

Keywords: intussusception gastroenteritis finland
iron therapy in patients with end-stage renal disease

Conditions: End-stage Renal Disease; Anemia; Cardiovascular Risk Factor; Inflammation

Summary: this study will compare the clinical outcome of patients with maintenance dialysis room after changing the iron treatment guidelines from original upper limit with ferritin\>500ng/ml, or tsat\>20% to ferritin\> 800ng / ml, or tsat\> 50%.

after two years of treatments, we will compare the incidence of clinical events, monthly blood, and biochemical examination data for the two years before and after the change.

Eligibility criteria:
inclusion criteria: * patients receiving maintenance dialysis exclusion criteria: * less than 20 year-old, oncological patients undergoing chemotherapy, abnormal liver function, infection

Keywords: iron end-stage renal disease anemia
study to evaluate the dynamic consent model based on the blockchain-based clinical trial platform metory

Conditions: COVID-19 Pneumonia

Summary: blockchain technology has gained attention for its decentralized feature and data integrity. the study aims to apply blockchain technology to implement dynamic consent model and evaluate the real-world experience as a form of virtual clinical trial.

the study will simulate a clinical trial that implements dynamic consent module. in this study, two major and three minor protocol amendments will be conducted on the scheduled date. each subjects will give consent using the dynamic consent platform, metory, and will be informed when the protocol is amended. the communication only be conducted under the metory and the real-world experience of metory would be evaluated.

Eligibility criteria:
inclusion criteria: * subjects who can use metory (application platform) * subjects who completely understand the study and voluntarily decide to participate in the study exclusion criteria: * subjects who are not able to use the web or application due to cognitive dysfunction or other reasons * subjects who are not able to measure body temperature by themselves * subjects who investigators decide not be appropriate for the study for other reasons

Keywords: blockchain, dynamic consent
a study of sovilnesib in subjects with ovarian cancer

Conditions: High Grade Serous Adenocarcinoma of Ovary; Fallopian Tube Cancer; Primary Peritoneal Carcinoma; Chromosomal Instability

Summary: this is a randomized, phase 1b study to assess the safety, tolerability, pharmacokinetics (pk), and efficacy of sovilnesib at different dose levels to establish the recommended phase 2 dose (rp2d) of sovilnesib in subjects with high grade serous ovarian cancer (hgsoc).

this is a randomized, phase 1b dose optimization study of sovilnesib in subjects with platinum-resistant hgsoc. the focus of the proposed clinical study is to establish the rp2d of sovilnesib in hgsoc. an adaptive multi-cohort design will be used to assess the safety, tolerability, pk, and efficacy of multiple dose levels in parallel to establish the rp2d of sovilnesib. the study will be conducted in 2 parts. part 1: 10 subjects will be randomized to each of the open dose levels to generate preliminary pk, pharmacodynamic (pd), safety, tolerability and efficacy data. early stopping rules for safety based on a bayesian toxicity monitoring design will be applied. part 2: based on review of the data from part 1, 20-30 additional subjects will be randomized to 2 or more dose levels examined in part 1. at the end of part 2, pk, pd, safety, tolerability and efficacy data will be used to determine the rp2d. early stopping rules for safety based on a bayesian toxicity monitoring design and for futility based on a bayesian efficacy monitoring via predictive probability design will be applied. sovilnesib will be given orally in 28-day cycles at selected dose levels of interest. dosing will continue until disease progression, unacceptable toxicity, withdrawal of consent, or other stopping criteria are met.

Eligibility criteria:
key inclusion criteria: * all parts: age ≥ 18 years, ecog performance status ≤ 1, at least 1 site of measurable disease evaluable by ct scan or mri per recist 1.1, able to take oral medication without alteration * high grade serous ovarian cancer, fallopian tube or primary peritoneal cancer - histologically or cytologically confirmed; metastatic or unresectable; platinum resistant (defined as recurrence within 6 months of platinum containing therapy) or platinum refractory; prior bevacizumab treatment, or ineligible or intolerant to bevacizumab, or did not receive bevacizumab based on investigator judgement; if germline and/or somatic brca1/2 mutation, previously treated with parp-inhibitor or ineligible or intolerant. key exclusion criteria: * msi-h, dmmr, pole gene hotspot mutated, or known hypermutator phenotype * endometrioid, clear cell, mucinous, sarcomatoid, low-grade/borderline ovarian tumor or mixed tumors containing any of the above histologies * previously received kif18a inhibitor * current cns metastases or leptomeningeal disease * cardiac parameters: mi or stroke ≤ 6 months, unstable angina/pe/dvt/cabg ≤ 6 months, nyha class ≥ ii, lvef \< 50% * any gastrointestinal condition (e.g. malabsorption syndrome, surgical anastomosis, short bowel syndrome) that might affect the absorption of oral medications including the study drug

Keywords: kif18a inhibitor
herbal treatment of hepatitis c in methadone maintained patients

Conditions: Hepatitis C

Summary: hepatitis c (hcv) is a chronic viral illness leading to progressive liver damage that has emerged as a major public health issue in the united states. while hcv affects all population groups, individuals with a history of intravenous drug use form the largest known risk group. between 90 and 100 percent of long term intravenous drug use will eventually test positive for hcv, and there is substantial risk that even short term experimentation will result in infection. studies suggest that hcv will be the major cause of cirrhosis and liver cancer in the next century. currently, approved therapy includes recombinant interferons, which lead to sustained remission in a minority of patients. however, patients abusing other substances, including alcohol, are not eligible for interferon therapy. the need for investigation into other potential therapies is clear. current practice patterns in the far east include the use of traditional herbal remedies for symptomatic chronic viral hepatitis. this study is intended to examine the effect of commonly used herbal remedies for the treatment of symptomatic hcv.


Eligibility criteria:
inclusion criteria: * english speaking/reading * serum positive for hcv virus by pcr * elevated alanine transferase (alt) within 6 months of the entry visit, unattributable to causes other than hcv * liver biopsy within 2 years of entry confirming that the histological diagnosis is consistent with chronic hcv * laboratory parameters available at the entry visit including cbc, differential, and platelet count.
artemether-lumefantrine (al) unit dose pre-packs versus blister packs

Conditions: Malaria

Summary: the purpose of this study is to determine if adherence and effectiveness of al in the treatment of uncomplicated malaria in children aged under five years using blister packs with pictorial leaflets can be at levels comparable to those with unit dosed age specific pre-packs.

prompt and adequate treatment of clinical malaria episodes remains one of the key elements of malaria control and this partly depends on patients' compliance to treatment. uganda adopted artemether-lumefantrine (al) as first line treatment for uncomplicated malaria. this is available at the health facilities in form of 6 dose pre-packs with different doze strengths in different packages. however, concerns about the costs and stock-outs of these packages have been raised and alternative equally efficacious alternatives need to be determined in order to reduce these problems. this study will assess if al blister-packs can act as alternatives to the unit dose age specific pre-packs in the public sector

Eligibility criteria:
inclusion criteria: * reported history of fever within last 48 hours and or an axillary temperature greater than or equal to 37.50c. * weight between 5 kg and 25 kg * positive malaria smear results for p. falciparum * no history of intake of al in the preceding two weeks * able to tolerate oral therapy * caregiver has given written informed consent to participate in the study * if they reside within the designated catchment area of the health facility exclusion criteria: * features of life threatening illness including severe malaria

Keywords: malaria